Contamination Control Process Owner — Biotech Manufacturing

Amgen Inc.; Holly Springs (NC); On-site; USD 108,000 - 146,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development opportunities

Job summary

Amgen Inc. in North Carolina seeks a Specialist Manufacturing – Contamination Control Process Owner to lead contamination control programs, implement CCS requirements, and coordinate readiness for regulatory inspections.

The role focuses on gowning, cleaning, material flow, and process optimization with a strong emphasis on training and continuous improvement within a GMP environment.

Qualifications

• Doctorate with 2 years biotechnology operations experience.
• Master's with 4 years biotechnology operations experience.
• Bachelor's with 6 years biotechnology operations experience.
• Associate's with 10 years biotechnology operations experience.
• High school diploma with 12 years biotechnology operations experience.

Responsibilities

• Own contamination control processes and SOPs for gowning, cleaning, and material flow.
• Implement CCS requirements and assess procedure gaps with Site Lead input.
• Support audits, inspections, and readiness activities for regulatory compliance.
• Lead RCAs, CAPAs, and change controls within scope of responsibilities.
• Coordinate training needs and document rationale for process-impacting changes.
• Track trends, effectiveness checks, and communicate risks to Site Lead.

Skills

Technical writing

Communication

Problem-solving

Organizational skills

Education

Doctorate degree in biotechnology operations

Master's degree in Engineering/Biology/Chemistry/Biochemistry or related

Bachelor's degree in biotechnology operations or related field

Associate's degree with 10 years of experience

High school diploma / GED with 12 years of biotechnology operations experience

Job description

Amgen Inc. in North Carolina seeks a Specialist Manufacturing – Contamination Control Process Owner to lead contamination control programs, implement CCS requirements, and coordinate readiness for regulatory inspections.

The role focuses on gowning, cleaning, material flow, and process optimization with a strong emphasis on training and continuous improvement within a GMP environment.